Systems and methods for transcutaneous control of implantable pulse generators for neuromodulation

ABSTRACT

Systems, devices and methods for providing neuromodulation are provided. One such system can include an implantable pulse generator. The implantable pulse generator can include a circuit board having a microcontroller that generates signals that are input into an ASIC. The ASIC serves as pulse generator that allows electrical pulses to be outputted into leads. The implantable pulse generator is capable of receiving and/or generating signals either via a wireless communication (e.g., a wireless remote control), a touching force (e.g., pressure from a finger), a motion sensor or any combination of the above.

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/044,209, filed Feb. 16, 2016, which was a nonprovisional applicationclaiming priority to provisional application U.S. 62/116,751, filed Feb.16, 2015, which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present application is generally directed to systems, devices andmethods for providing neuromodulation.

BACKGROUND OF THE INVENTION

Neuromodulation is a treatment that delivers either electricity or drugsto nerves in order to change their activity. Neuromodulation is the namefor an overall category of treatment, one that can be used for a varietyof diseases and symptoms. For example, neuromodulation can be used totreat spinal cord damage, headaches, Parkinson's disease, chronic backpain and even deafness.

Neuromodulation is used to treat and enhance quality of life inindividuals who suffer severe chronic illness due to persistent pain,spasticity, movement disorders, epilepsy, ischaemic, cardiac, bowel andbladder dysfunction, spinal injury, visual, auditory, and specificpsychiatric disorders. Neuromodulation is typically not used to removethe source of pain. Rather, it is typically used to mask pain.

To enable neuromodulation, an implantable pulse generator (IPG) can beimplanted into a patient. The implantable pulse generator can generateelectrical pulses for therapeutic purposes. It is desirable to havedifferent systems and methods that enable neuromodulation and controlthe output parameters of an implantable pulse generator.

SUMMARY OF THE INVENTION

Various systems, devices and methods related to neuromodulation areprovided. In some embodiments, a system for exerting pulses to atargeted site within a body comprises an implantable pulse generator.The implantable pulse generator comprises a casing housing a circuitboard, wherein the circuit board contains circuitry comprising amicrocontroller and as ASIC, wherein the microcontroller is configuredto receive signals generated from a wireless remote control and atouching force, wherein the ASIC is configured to receive data from themicrocontroller to generate electrical signals. In addition, theimplantable pulse generator comprises a lead contact assembly operablyconnected to the ASIC, wherein the lead contact assembly comprises aplurality of leads that are used to carry electrical signals from theIPG to the targeted site within the body.

In some embodiments, a system for exerting pulses to a targeted sitewithin a body comprises an implantable pulse generator. The implantablepulse generator comprises a casing housing a circuit board, wherein thecircuit board contains circuitry comprising a microcontroller and asASIC, wherein the microcontroller is configured to receive signalsgenerated from a touching force, wherein the ASIC is configured toreceive data from the microcontroller to generate electrical signals. Inaddition, the implantable pulse generator comprises a lead contactassembly operably connected to the ASIC, wherein the lead contactassembly comprises a plurality of leads that are used to carryelectrical signals from the IPG to the targeted site within the body.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more readily understood with reference to theembodiments thereof illustrated in the attached figures, in which:

FIG. 1 shows one example of an IPG that can be controlled by wirelessremote and which can benefit from the addition of touch and motionsensors.

FIG. 2 shows a block diagram of an IPG of a neuromodulation devicehaving both wireless capabilities and touch and motion sensors inaccordance with some embodiments.

FIG. 3 shows a block diagram of a motion sensor that can be incorporatedinto the IPG shown in FIG. 2.

FIG. 4 shows a block diagram whereby multiple sensors are provided in asingle device.

FIG. 5 shows an IPG utilizing four touch sensors.

FIG. 6 illustrates the process of a user providing a clockwise sweepinggesture around the four touch sensors to generate an output.

FIG. 7 shows a chart of a voltage output as sensors are touched in asequential, counterclockwise manner in accordance with one embodiment.

FIG. 8 shows an IPG utilizing four touch sensors.

FIG. 9 illustrates the process of a user providing a counter clockwisesweeping gesture around the four touch sensors to generate an output.

FIG. 10 shows a chart of a voltage output as sensors are touched in asequential, counterclockwise manner in accordance with one embodiment.

FIG. 11 shows an electronic circuit that can be used to read the outputgenerated by the one or more touch or motion sensors.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Embodiments of the invention will now be described. The followingdetailed description of the invention is not intended to be illustrativeof all embodiments. In describing embodiments of the present invention,specific terminology is employed for the sake of clarity. However, theinvention is not intended to be limited to the specific terminology soselected. It is to be understood that each specific element includes alltechnical equivalents that operate in a similar manner to accomplish asimilar purpose.

The present application relates to systems and methods fortranscutaneous control of implantable pulse generators (IPGs) used inneuromodulation. The IPGs can be used to treat a variety of illnesses,including but not limited to persistent pain, spasticity, movementdisorders, epilepsy, ischaemic, cardiac, bowel and bladder dysfunction,spinal injury, visual, auditory, and specific psychiatric disorders. Insome embodiments, an IPG is used for spinal cord stimulation (SCS),whereby the IPG sends pulsed electrical signals to the spinal cord tocontrol chronic pain.

An IPG can be used to deliver electrical pulses to treat chronic pain.In some embodiments, an IPG is implanted subcutaneously in a patient.The IPG can be attached to stimulation electrodes that deliverelectrical pulses to specific sites. For example, in spinal cordstimulation, one or more electrodes can be implanted directly into anepidural space.

An IPG can serve multiple functions. In some embodiments, an IPG canconsist of a battery and a circuit board that provides and controls thecurrents of electrical stimulation. In some embodiments, the IPG cancomprise a microcontroller transceiver component and anapplication-specific integrated circuit (ASIC) component. Thetransceiver can be used to receive, decode and execute commands andrequests from a remote control. These commands and requests can bepassed onto the ASIC. The ASIC receives the digital data from themicrocontroller and performs the entire signal processing to generatethe signals necessary for stimulation. In some embodiments, the ASICserves as a pulse generator. These signals are then passed onto thestimulation electrodes, which can then deliver pulses to a desired site.

Devices such as IPGs can be controlled wirelessly by external hand heldremote controls outside of the body. In some embodiments, these remotescan communicate with the IPG by radiofrequency or induction. The remotescan be used to perform a number of functions, including but not limitedto turning stimulation ON and OFF, increasing or decreasing theamplitude of stimulation, and changing programs.

While IPGs have been successfully controlled by remote controls, the useof remote controls is not always practical. There may be instances whenthe wireless connection between the remote control and the IPG goes out.In addition, there may be times when using a remote control, such as inheavy rain, in the shower, or in a swimming pool, may not be feasible.Furthermore, a patient may simply forget to bring a remote control withthem.

Accordingly, the present application discloses systems and methods forcontrolling implanted devices, such as IPGs, in ways other than wirelessremote controls. In particular, the present application discloses novelsystems and methods for communicating with IPGs whereby touch sensorsand/or motion sensors will be used in the IPGs, and the communication tocontrol the stimulation is by touch and motion gestures. In someembodiments, the communication to control the stimulation istranscutaneous.

FIG. 1 shows one example of an IPG that can be controlled by wirelessremote and which can benefit from the addition of touch and motionsensors. In some embodiments, the IPG 102 comprises a casing 120 thathouses a battery 108, a circuit board 105, and charging coil 109. Thecircuit board 105 contains circuitry including a transceiver 104, ASIC106, and output capacitors 112. The IPG 102 further includes an epoxyheader 114 which houses a lead contact assembly 116, locking housing 118and antenna 110. The lead contact assembly 116 comprises a plurality ofstimulation leads that are used to carry electrical signals from the IPGto targeted stimulation areas. In some embodiments, the leads of thelead contact assembly 116 are secured to the IPG 102 via one or more setscrews 119 that operate within the locking housing 118. The internalelectronics (e.g., from the circuit board 105) are connected to thecomponents within the epoxy header 114 through a hermetic feedthrough122. The IPG 102 further comprises electrical contacts 126 that can forman electrical connection between the circuit board and the leadcontacts. In some embodiments, the electrical contacts 126 can bearranged in four rows of eight contacts.

The IPG in FIG. 1 can benefit from the addition of touch and motionsensors. In particular, one or more touch and motion sensors canadvantageously be added, including piezoelectric sensors,magnetostrictive sensors, accelerometers, and gyroscopes. In someembodiments, the motion sensors can comprise MEMS-based accelerometers.Each of these sensors provides added benefits to the IPG. A touchgesture performed on the surface of a patient's body can be read bypiezo-type sensors mounted on the surface of the IPG. A motion or impactgesture performed on the surface of a patient's body can be read byaccelerometers mounted inside the IPG. The IPG then interprets thesegestures by using electronic circuits and software algorithms programmedin them.

FIG. 2 shows a block diagram of an IPG of a neuromodulation devicehaving both wireless capabilities and touch and motion sensors inaccordance with some embodiments. In some embodiments, the IPG will havea wireless module (similar to as shown in FIG. 1) for wirelesscommunication and induction modular for wireless charging of thebattery. In addition to these modules, the IPG also includes touchsensors and/or motion sensors. In some embodiments, the IPG includesonly touch or only motion sensors, while in other embodiments, itincludes both. In addition, in some embodiments, multiple touch and/ormotion sensors can be included in the IPG.

As shown in the block diagram in FIG. 2, the touch and motion sensorsoutput analog voltage (or current) corresponding to the magnitude of theinput. The output signals from the touch and motion sensors are fed intoone or more signal conditioning circuits to scale them to a voltagerange readable by one or more microcontrollers. In some embodiments, asshown in FIG. 2, each of the touch sensors and motion sensors has itsown associated signal conditioning circuits, which are then fed into asingle microcontroller. The scaled sensor output can be read by usingexternal analog to digital converter modules, or by built-in moduleswithin the microcontroller itself. Commands can then be passed on fromthe microcontroller to the ASIC, whereby one or more electrode outputscan be generated.

FIG. 3 shows a block diagram of a motion sensor that can be incorporatedinto the IPG shown in FIG. 2. In some embodiments, the motion sensorcomprises an accelerometer (e.g., a 3-axis accelerometer) or an impactsensor that can be used to sense tapping gestures from a human (e.g., adoctor or the patient himself). When the user taps in a certain patternon the surface of the skin where the neuromodulation device isimplanted, the electronics inside will detect the tapping gesture andperform the task related to the tapping gesture. As an example, a singletap can be used to turn OFF the stimulation and a quick double tap canbe used to turn ON the stimulation. A series of multiple taps withdecreasing impact can be used to decrease the stimulation amplitude.Impacts in other axes can be used to communicate other controls such aschanging the program. In some embodiments, as shown in the circuits inFIG. 3, either a microcontroller that can independently read multipleanalog signals or a multiplexer can be used to read the sensors oneafter the other selectively.

In some embodiments, the IPG will advantageously be protected againstaccidental pushes of the touch or motion sensor. For example, the IPGcan include multiple sensors such that in order to modify an electricpulse, the multiple sensors would need to be pushed in an alternatingpattern. This advantageously reduces the likelihood that the IPG will beinadvertently pushed (e.g., by an individual bumping into another),thereby having better control over the pulses generated by the IPG. Inother embodiments, one or more sensors can be programmed to have apressure threshold which must be reached before any action is taken.These safeguards can be used, either alone or in combination, to reducethe risk of inadvertent actuation of the IPG.

FIG. 4 shows a block diagram whereby multiple sensors are provided in asingle device. Advantageously, the use of multiple sensors will make thetouch controls easier. In some embodiments, each sensor can be fedthrough a signal conditioner and read through a dedicated analog todigital converter. In other embodiments, each sensor can be readselectively using a multiplexer.

FIG. 5 shows an IPG utilizing four touch sensors 201, 202, 203, 204. Thefour sensors are arranged such that they can be sequentially touched ina clockwise manner. In some embodiments, to actuate a signal from theIPG, a clockwise sweeping motion over one or more of the touch sensors201, 202, 203, 204 can be used.

FIG. 6 illustrates the process of a user providing a clockwise sweepinggesture around the four touch sensors 201, 202, 203, 204 to generate anoutput. The four touch sensors can be touched sequentially to produce anoutput, with sensor 201 being excited first, followed by sensor 202, 203and then 204. In some embodiments, more than one rotation of the fourtouch sensors 201, 202, 203, 204 is needed to generate an output. Inother embodiments, a single complete rotation is needed to produce anoutput, but additional rotations can modify the output. For example, insome embodiments, a clockwise sweep past a single rotation can increasethe amplitude of a stimulation. In other embodiments, such a clockwisesweep can decrease the amplitude of a stimulation. FIG. 7 shows a chartof a voltage output as the sensors 201, 202, 203, 204 are touched in asequential, counterclockwise manner in accordance with one embodiment.

FIG. 8 shows an IPG utilizing four touch sensors 201, 202, 203, 204. Thefour sensors are arranged such that they can be sequentially touched ina counter clockwise manner. In some embodiments, to actuate a signalfrom the IPG, a counter clockwise sweeping motion over one or more ofthe touch sensors 201, 202, 203, 204 can be used.

FIG. 9 illustrates the process of a user providing a counter clockwisesweeping gesture around the four touch sensors 201, 202, 203, 204 togenerate an output. The four touch sensors can be touched sequentiallyto produce an output, with sensor 204 being excited first, followed bysensor 203, 202 and then 201. In some embodiments, more than onerotation of the four touch sensors 201, 202, 203, 204 is needed togenerate an output. In other embodiments, a single complete rotation isneeded to produce an output, but additional rotations can modify theoutput. For example, in some embodiments, a counter clockwise sweep pasta single rotation can decrease the amplitude of a stimulation. In otherembodiments, such a counter clockwise sweep can increase the amplitudeof a stimulation. FIG. 10 shows a chart of a voltage output as thesensors 201, 202, 203, 204 are touched in a sequential, countercounterclockwise manner in accordance with one embodiment.

FIG. 11 shows an electronic circuit that can be used to read the outputgenerated by the one or more touch or motion sensors 201, 202, 203, 204.In some embodiments, one or more operational amplifiers can be used tocondition the signal generated by one or more of the sensors 201, 202,203, 204 to make it readable by further electronics. The same circuitcan be duplicated to read other sensors as well.

While the embodiments described above illustrate an IPG device havingcertain features (e.g., four touch sensors), one skilled in the art willappreciate that the IPG device can have less than or greater than fourtouch sensors. In addition, the sensors can be a variety of touch and/ormotion sensors. Furthermore, as noted above, the touch and/or motionssensors can be provided in conjunction with the IPGs wirelesscapabilities, thereby providing different means to generate an output bythe IPG.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations can be made thereto by those skilled in the art withoutdeparting from the scope of the invention.

What is claimed is:
 1. A system for exerting stimulation pulses to atargeted site within a body comprising: an implantable pulse generator,wherein the implantable pulse generator comprises: a casing housing acircuit board, wherein the circuit board contains circuitry comprising amicrocontroller, at least one touch sensor and an ASIC, wherein themicrocontroller is configured to receive signals generated from awireless remote control and the at least one touch sensor when the atleast one touch sensor is subjected to a predetermined touching force,wherein the ASIC is configured to receive data from the microcontrollerto generate the stimulation pulses; and a lead contact assembly operablyconnected to the ASIC, wherein the lead contact assembly comprises aplurality of leads that are used to carry the stimulation pulses fromthe IPG to the targeted site within the body.
 2. The system of claim 1,wherein the at least one touch sensor comprises a plurality of touchsensors for generating a signal based on the touching force.
 3. Thesystem of claim 2, wherein the predetermined touching force comprises apredetermined pattern, and wherein the electrical signals will not begenerated until the predetermined pattern is detected.
 4. The system ofclaim 3, wherein the plurality of touch sensors comprises at least fourtouch sensors for generating a signal based on the predeterminedtouching force.
 5. The system of claim 4, wherein the at least fourtouch sensors are configured to generate a signal when they are touchedsequentially in the predetermined pattern.
 6. The system of claim 1,wherein the lead contact assembly comprises at least one set screw forsecuring the plurality of leads to other components of the IPG.
 7. Thesystem of claim 1, wherein the implantable pulse generator comprises atleast one accelerometer.
 8. The system of claim 1, further comprising anexternal remote control for generating a signal within the IPG.
 9. Thesystem of claim 1, wherein the implantable pulse generator comprises atleast a pair of touch and motion sensors.
 10. The system of claim 9,wherein the pair of touch and motion sensors send signals into themicrocontroller.
 11. A system for exerting stimulation pulses to atargeted site within a body comprising: an implantable pulse generator,wherein the implantable pulse generator comprises: a casing housing acircuit board and a plurality of sensors, wherein the circuit boardcontains circuitry comprising a microcontroller and an ASIC, wherein themicrocontroller is configured to receive signals generated from apredetermined touching force being applied to the plurality of sensors,wherein the ASIC is configured to receive data from the microcontrollerto generate the stimulation pulses; and a lead contact assembly operablyconnected to the ASIC, wherein the lead contact assembly comprises aplurality of leads that are used to carry the stimulation pulses fromthe IPG to the targeted site within the body.
 12. The system of claim11, wherein the plurality of sensors are housed on the circuit board andwherein the plurality of sensors generate a plurality of signals thatare received into the microcontroller.
 13. The system of claim 11,wherein the plurality of leads are sized and configured to extend intoan epidural for spinal cord stimulation.
 14. The system of claim 12,wherein the plurality of sensors comprises at least four touch sensorsfor generating a signal based on the predetermined touching force. 15.The system of claim 14, wherein the at least four touch sensors areconfigured to generate the signal when they are touched in apredetermined pattern.
 16. The system of claim 11, wherein the leadcontact assembly comprises at least one set screw for securing theplurality of leads to other components of the IPG.
 17. The system ofclaim 11, wherein the implantable pulse generator comprises at least oneaccelerometer.
 18. The system of claim 11, further comprising anexternal remote control in communication with the implantable pulsegenerator for generating a signal therein.
 19. The system of claim 11,wherein the plurality of sensors comprises at least a pair of touch andmotion sensors.
 20. The system of claim 19, wherein the pair of touchand motion sensors send signals into the microcontroller.